Locally Advanced Solid TumorPhase 1NCT05769075
A Study of TY-2136b in Patients With Advanced Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Alterations
A Phase 1 study testing TY-2136b in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by TYK Medicines, Inc at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of TY-2136b and to determine the recommended phase 2 dose (RP2D), with dose-escalation stage and dose-expansion stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- TY-2136b
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2023to Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).
- In the escalation stage, patients should fulfill the following criterion at Screening:
- Age ≥18 years.
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor. Evidence of ALK, ROS1, NTRK1, NTRK2 or NTRK3 alterations in tumor tissue or blood, as determined with prior molecular assays performed in a CLIA-certified or equivalent laboratory.
- Patients must have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds. Note: Prior cytotoxic chemotherapy is allowed; prior anti-cancer immunotherapy is allowed.
- In the expansion stage, patients should fulfill the following criteria at Screening:
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- Age ≥18 years.
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and other solid tumors.
- Subject must have a documented ROS1 or NTRK1-3 gene or ALK fusion or rearrangement determined by CLIA-certified or equivalent testings. Next-generation sequencing (NGS), quantitative polymerase chain reaction (qPCR) test or fluorescence in situ hybridization (FISH).
- ECOG Performance Status 0-1.
- Capability to swallow intact tablet without chewing or opening; if the patient cannot swallow many tablets of high dose at one time, the subject can take dissolving tablets orally.
- At least 1 measurable target lesion according to Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) determined by the investigator. Subjects with central nervous system (CNS)-only measurable disease ≥10 mm as defined by RECIST v1.1 are eligible.
- All acute toxic effects (excluding alopecia of any prior anticancer therapy recovered to grade ≤1 based on NCI CTCAE v5.0).
- Patients with asymptomatic CNS metastases (treated or untreated) are also eligible if they satisfy the other criteria specified in this protocol.
- Baseline laboratory results fulfilling the requirements.
- Life expectancy ≥3 months.
- For female patients of childbearing potential, the serum or urine pregnancy test within 72 hours prior to the start of TY-2136b treatment should be negative.
- Male and female patients of childbearing potential must agree to use 2 methods of highly effective contraception from signing ICF, throughout the study and continued for 90 days after the last dose of TY-2136b treatment.
- Willing and able to comply with all aspects of the protocol.
Who cannot join
- Concurrent participation in another therapeutic clinical trial. Unless the patient is during follow-up period of a previous interventional clinical trial.
- Symptomatic CNS metastases, OR leptomeningeal involvement.
- History of other previous cancer (except for squamous cell or basal-cell carcinoma of the skin, any in situ carcinoma that has been completely resected, or other early-stage malignancies receiving curative treatment which get consensus between the investigators and sponsor), requiring therapy within the previous 2 years.
- Major surgery within 4 weeks prior to the start of TY-2136b treatment; OR radiation therapy (except palliative to relieve bone pain) within 2 weeks prior to enrollment. Note: Palliative radiation must have been completed at least 48 hours prior to enrollment.
- Patients receiving long-term systemic immunosuppressant therapy (≤10 mg/ day of prednisone or another equivalent dose of corticosteroid inhalation or topical administration can be included);
- Clinically significant cardiovascular disease (either active at Screening or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥II), cerebrovascular accident or transient ischemic attack, stroke, symptomatic bradycardia, or requirement for anti-arrhythmic medication; or cardiac dysrhythmias of NCI CTCAE grade ≥2 deemed of clinical significance by the investigator.
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- Any of the following cardiac criteria:
- Mean resting corrected QT interval (electrocardiogram interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTcF) >470 msec obtained from 3 electrocardiograms, using the screening clinic electrocardiogram machine derived QTc value.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 msec).
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval during Screening.
- Known active infections, e.g., bacterial, fungal and viral infections, including human immunodeficiency virus (HIV) infection (defined as anti-HIV antibody positive), hepatitis B virus (HBV) infection [defined as Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥1000 cps/mL or 200 IU/mL] and hepatitis C virus (HCV) infection (defined as anti-HCV antibody positive and HCV-RNA positive). Human Immunodeficiency Virus (HIV) positive patients could be eligible after discussion with medical monitor based on current and past CD4 and T-cell counts, history (if any) of AIDS-defining conditions (e.g., opportunistic infections), and status of HIV treatment.
- Active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) or other malabsorption syndromes that will impact drug absorption.
- Peripheral neuropathy of CTCAE ≥ grade 2.
- History of extensive, disseminated, bilateral or CTCAE grade 3 or 4 interstitial fibrosis or interstitial lung disease (ILD) including pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, ILD, obliterative bronchiolitis, and pulmonary fibrosis. Note: Patients with history of prior radiation pneumonitis will not be excluded.
- History of strong inhibitors and/or inducers of CYP3A within 2 weeks prior to the first dose of TY-2136b.
- History of strong inhibitors and/or inducers of P-glycoprotein within 2 weeks prior to the first dose of TY-2136b.
- History of sensitive substrates and those with a narrow therapeutic index of CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A within 2 weeks prior to the first dose of TY-2136b.
- History of proton pump inhibitors (PPIs) within 4 days prior to the first dose of TY-2136b; OR history of histamine H2 blockers within 2 days prior to the first dose of TY-2136b.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Oncology Consultants
Houston, Texas, 30322
Peguero Julio, MD, 713-600-0913, jpeguero@OncologyConsultants.com
- Recruiting
Rhode Island Hospital, Brown University
Providence, Rhode Island, 02903
Benedito Carneiro, MD, 401-444-3243, benedito_carneiro@brown.edu
About this study
Official title: A Phase I, Multicenter, Open-label Study of TY-2136b, Administered Orally in Patients With Advanced or Metastatic Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Alterations
The primary objective of this study is to evaluate the safety and tolerability of TY-2136b and to determine the recommended phase 2 dose (RP2D), with dose-escalation stage and dose-expansion stage.
Read the detailed description
- To evaluate the pharmacokinetic (PK) characteristics of TY-2136b after single and multiple oral doses.
- To assess preliminary antitumor activity of TY-2136b as a single agent when administered orally to patients with advanced or metastatic solid tumors.
- To identify mutations in the ALK, ROS1 and NTRK1-3, or other molecular alterations in blood or tumor tissues associated with clinical outcome.
- Being tested
- TY-2136b
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TY-2136bDrug
Drug: TY-2136b PO, QD or BID
Escalation stage: 7 increased dose cohorts from low dose to MTD (from 40mg QD to 420mg QD)
TY-2136bDrug
Expansion stage: 4 distinct cohorts
The dose for the Expansion stage will be determined based on results from the Escalation stage
| Study group | Role | What they receive |
|---|---|---|
| Escalation stage | Experimental | Escalation stage: Multiple doses of TY-2136b for oral administration to find the maximum tolerated dose Receives: Drug: TY-2136b |
| Expansion stage | Experimental | Expansion stage: 4 distinct expansion cohorts Receives: Drug: TY-2136b |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Escalation stage) Dose Limiting Toxicities (DLTs)
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE v5.0.
Measured: Within 28 days of the first dose
(Escalation stage) Recommended Phase 2 Dose (RP2D)
The RP2D is defined as the dose level chosen for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.
Measured: Within 28 days of the last patient dosed in escalation stage
(Escalation stage) Adverse events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: From Baseline up to 28 days after the end of the treatment
(Expansion stage) Overall Response Rate (ORR)
ORR is defined as the percentage of subjects who have a partial response (PR) or complete response (CR) to the treatment response assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Measured: From the date of first dose until the date of first documented progression or stable disease or the date of death from any cause, whichever came first, assessed up to 30 months.
Secondary outcomes (10)
(Escalation and Expansion stage) Area under the plasma concentration time curve(AUC0-inf)
AUC0-inf defined as the area under the plasma concentration-time curve from time 0 extrapolated to Infinite time.
Measured: Cycle 1 Day 1 (at pre-dose, 0.5, 1, 2, 4, 6, 24 h post-dose) (Each Cycle=28 days)
(Escalation and Expansion stage) Area under the plasma concentration time curve(AUC0-t)
AUC0-t defined as area under the plasma concentration-time curve from time 0 to time t.
Measured: Cycle 1 Day 1 and Cycle 1 Day 21 (at pre-dose, 0.5,1, 2, 4, 6, 24 hours post-dose)(Each Cycle=28 days)
(Escalation and Expansion stage) Maximum plasma concentration (Cmax)
Cmax is the maximum (or peak) plasma concentration that the drug achieves in blood after the drug has been administered.
Measured: Cycle 1 Day1 and Cycle 1 Day 21 (at pre-dose, 0.5,1, 2, 4, 6, 24 hours post-dose)(Each Cycle=28 days)
(Escalation and Expansion stage) Minimum plasma concentration (Cmin)
Cmin is the minimum plasma concentration that the drug achieves in blood after the drug has been administered.
Measured: Cycle1 Day 21 (at pre-dose, 0.5,1, 2, 4, 6, 24 hours post-dose)(Each Cycle=28 days)
(Escalation and Expansion stage) Terminal half-life (t1/2)
T1/2 is defined as the time for the concentration of a compound in sytemic circulation to reduce by half.
Measured: Cycle1 Day 1 and Cycle1 Day 21 (at pre-dose, 0.5,1, 2, 4, 6, 24 hours post-dose)(Each Cycle=28 days)
(Escalation and Expansion stage) The time to the peak concentration (Tmax)
Tmax is defined as the time of maximum concentration of the drug in blood observed after a drug dose administration.
Measured: Cycle1 Day 1 and Cycle1 Day 21 (at pre-dose, 0.5,1, 2, 4, 6, 24 hours post-dose)(Each Cycle=28 days)
(Escalation and Expansion stage) Progression-free survival (PFS)
PFS is defined as the time from randomization until first evidence of disease progression or death.
Measured: Up to 30 months after the date of first dose.
(Escalation and Expansion stage) Duration of Response (DOR)
DOR is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response.
Measured: Up to 30 months after the date of first dose.
(Escalation and Expansion stage) Overall survival (OS)
OS is defined as the time from the start of treatment to death or the end of the study.
Measured: Up to 30 months after the date of first dose.
(Escalation stage) Overall Response Rate (ORR)
ORR is defined as the percentage of subjects who have a partial response (PR) or complete response (CR) to the treatment response assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Measured: From the date of first dose until the date of first documented progression or stable disease or the date of death from any cause, whichever came first, assessed up to 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start20 Apr 2023
- Primary completionJan 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TYK Medicines, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TYK Medicines, Inc, Study director, TYK Medicines, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769075
- Sponsor's protocol ID
- TYKM7203101
- Status last verified
- Apr 2023
- First submitted
- 9 Feb 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label Study of TY-2136b, Administered Orally in Patients With Advanced or Metastatic Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Alterations
- ClinicalTrials.gov ID
- NCT05769075
- Acronym / sponsor ID
- TYKM7203101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- TYK Medicines, IncIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of TY-2136b and to determine the recommended phase 2 dose (RP2D), with dose-escalation stage and dose-expansion stage.
Detailed description
- To evaluate the pharmacokinetic (PK) characteristics of TY-2136b after single and multiple oral doses.
- To assess preliminary antitumor activity of TY-2136b as a single agent when administered orally to patients with advanced or metastatic solid tumors.
- To identify mutations in the ALK, ROS1 and NTRK1-3, or other molecular alterations in blood or tumor tissues associated with clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escalation stage | Experimental | Drug: TY-2136bEscalation stage: Multiple doses of TY-2136b for oral administration to find the maximum tolerated dose |
| Expansion stage | Experimental | Drug: TY-2136bExpansion stage: 4 distinct expansion cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Willing and able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).
- In the escalation stage, patients should fulfill the following criterion at Screening:
- ECOG Performance Status 0-1.
- Capability to swallow intact tablet without chewing or opening; if the patient cannot swallow many tablets of high dose at one time, the subject can take dissolving tablets orally.
- At least 1 measurable target lesion according to Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) determined by the investigator. Subjects with central nervous system (CNS)-only measurable disease ≥10 mm as defined by RECIST v1.1 are eligible.
Key exclusion criteria (18 listed)
- Concurrent participation in another therapeutic clinical trial. Unless the patient is during follow-up period of a previous interventional clinical trial.
- Symptomatic CNS metastases, OR leptomeningeal involvement.
- History of other previous cancer (except for squamous cell or basal-cell carcinoma of the skin, any in situ carcinoma that has been completely resected, or other early-stage malignancies receiving curative treatment which get consensus between the investigators and sponsor), requiring therapy within the previous 2 years.
- Major surgery within 4 weeks prior to the start of TY-2136b treatment; OR radiation therapy (except palliative to relieve bone pain) within 2 weeks prior to enrollment. Note: Palliative radiation must have been completed at least 48 hours prior to enrollment.
- Patients receiving long-term systemic immunosuppressant therapy (≤10 mg/ day of prednisone or another equivalent dose of corticosteroid inhalation or topical administration can be included);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TY-2136bDrug: TY-2136b PO, QD or BID Escalation stage: 7 increased dose cohorts from low dose to MTD (from 40mg QD to 420mg QD) | Drug | Escalation stage |
| TY-2136bExpansion stage: 4 distinct cohorts The dose for the Expansion stage will be determined based on results from the Escalation stage | Drug | Expansion stage |
Primary outcome
(Escalation stage) Dose Limiting Toxicities (DLTs)
Time frame: Within 28 days of the first dose
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE v5.0.
(Escalation stage) Recommended Phase 2 Dose (RP2D)
Time frame: Within 28 days of the last patient dosed in escalation stage
The RP2D is defined as the dose level chosen for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.
(Escalation stage) Adverse events (AEs)
Time frame: From Baseline up to 28 days after the end of the treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
(Expansion stage) Overall Response Rate (ORR)
Time frame: From the date of first dose until the date of first documented progression or stable disease or the date of death from any cause, whichever came first, assessed up to 30 months.
ORR is defined as the percentage of subjects who have a partial response (PR) or complete response (CR) to the treatment response assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
10 secondary outcomes
(Escalation and Expansion stage) Area under the plasma concentration time curve(AUC0-inf)
Time frame: Cycle 1 Day 1 (at pre-dose, 0.5, 1, 2, 4, 6, 24 h post-dose) (Each Cycle=28 days)
(Escalation and Expansion stage) Area under the plasma concentration time curve(AUC0-t)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 21 (at pre-dose, 0.5,1, 2, 4, 6, 24 hours post-dose)(Each Cycle=28 days)
(Escalation and Expansion stage) Maximum plasma concentration (Cmax)
Time frame: Cycle 1 Day1 and Cycle 1 Day 21 (at pre-dose, 0.5,1, 2, 4, 6, 24 hours post-dose)(Each Cycle=28 days)
(Escalation and Expansion stage) Minimum plasma concentration (Cmin)
Time frame: Cycle1 Day 21 (at pre-dose, 0.5,1, 2, 4, 6, 24 hours post-dose)(Each Cycle=28 days)
(Escalation and Expansion stage) Terminal half-life (t1/2)
Time frame: Cycle1 Day 1 and Cycle1 Day 21 (at pre-dose, 0.5,1, 2, 4, 6, 24 hours post-dose)(Each Cycle=28 days)
(Escalation and Expansion stage) The time to the peak concentration (Tmax)
Time frame: Cycle1 Day 1 and Cycle1 Day 21 (at pre-dose, 0.5,1, 2, 4, 6, 24 hours post-dose)(Each Cycle=28 days)
(Escalation and Expansion stage) Progression-free survival (PFS)
Time frame: Up to 30 months after the date of first dose.
(Escalation and Expansion stage) Duration of Response (DOR)
Time frame: Up to 30 months after the date of first dose.
(Escalation and Expansion stage) Overall survival (OS)
Time frame: Up to 30 months after the date of first dose.
(Escalation stage) Overall Response Rate (ORR)
Time frame: From the date of first dose until the date of first documented progression or stable disease or the date of death from any cause, whichever came first, assessed up to 30 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhode Island Hospital, Brown University
Providence, United States
TYK Medicines, Inc study director
TYK Medicines, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TY-2136b in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by TYK Medicines, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Escalation stage) Dose Limiting Toxicities (DLTs) (time frame: Within 28 days of the first dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.